Changing Perceptions: EQMS as a Value Generator in the Medical Device Industry

May 5, 2014

By Sparta Editorial


Every enterprise wants to build their products safer, quicker and cheaper. None of these would be possible if the products did not contain the level of quality to retain reliability and safety. Current industrial trends point to the use of global supplier networks and effective supplier relationship management metrics that apply across many industries. However, given the nature of the medical device industry, effective management of supplier relationships and continual insight into the supply chain process can be crucial to preventing recalls or being able to react quickly and effectively manage in the event of a recall. Due to many suppliers both in the U.S. and abroad working under different regulatory bodies or requirements, there may not be a transparent view of data. Unfortunately, a substantial number of suppliers regard fluid and constant sharing of data as a cost or obstacle to the timely completion of a product rather than a value generator.

Just consider this metric – 52% of the recalls are caused by supplier related issues, whether they are non-conforming material or process used as part of the supplier delivered parts. When you consider the cost and resources it takes to remediate, replace, repair and recall, it is even more apparent that proactive measures of supplier quality metrics are value generating because they reduce costs.

Supplier Quality Metrics In the Face of Increased Recalls

A recent article in the Wall Street Journal noted that the FDA has found that medical device recalls have nearly doubled in the past decade, rising from 604 recalls in 2003 to 1,190 in 2012. A report by the Center for Devices and Radiological Health (CDRH) attributed the growing amount of recalls to the fact that there are now a lot more and sophisticated medical devices on the market -- particularly personalized and targeted devices for more specific use as opposed to more general use.

Enterprise Quality Management Solutions (EQMS) makes management of data much simpler and more efficient in terms of allowing manufacturers to be able to trace, track, and assign accountability to specific people, parties, and/or departments in the event of a recall. Recalls only happen when a noticeable trend occurs that points to a product being dangerous. Significant documentation is required including Corrective Actions/Preventive Actions (CAPAs) and insight into what companies did leading up to a recall, as well as during the recall process.

Issues with a medical device reported by the end user, health care professional, or health care facility must be logged, triaged, and recorded. In certain cases of injury, serious injury or death, they are required to file an MDR within 5 to 30 days. When the FDA sees an adverse product safety trend, they call for a recall.

FDA states in the recent Medical Device Recall Report that having an effective Quality Management System can reduce the likelihood of non-conforming materials being the major cause of majority of the Class I recalls in the past decade.

Upon review of data, the manufacturer can see how many occurrences happened in a year. An instance of one or two reports is not enough to produce a trend. However, a pattern of regular occurrences in the past year can indicate such a trend. By looking back at the lot numbers of those products to narrow the data, manufacturers can determine where the problem occurred, down to the specific lot number.

Three Steps for Communicating a Recall

A Quality Management Solution (QMS) makes communicating a recall much more efficient, saving time, cost, and lives in the process and implementing an EQMS can help prevent a recall before it happens. For now, the onus is on manufacturers to be able to effectively communicate a recall to the FDA. Here are three steps that should be taken when communicating a recall report:

  1. Manufacturers must be able to query extensive data to quickly produce the correct data surrounding a product or component. In the event of a recall, manufacturers must be able to query not just raw data -- but raw data, parameters, and the correct range field of data in a meaningful way.

  2. With this data in-hand, manufacturers should be able to produce CAPA and audit reports quickly, establishing accountability. A correlation must be in place between data itself and what was done as a result of findings.

  3. Finally, by having a system of accountability and the ability to schedule revised audits and effectiveness, a manufacturer must be able to prove that the changes were made in a timely fashion and a remediation plan is in place.

Uniform Coding as an Enhancement to Supply Chain Performance Metrics & Tracking

The FDA’s recent Unique Device Identification (UDI) legislation and the creation of the GUDID compliance database underscores the need for certain parties in the industry to change their perception of an EQMS as a hindrance to the process. This legislation calls for more consistent and standardized communication across the medical device supply chain.

Prior to creation of the UDI system, various links in the medical device value chain -- manufacturers, distributors, suppliers, hospitals, and insurance companies -- each had their own codes for the same products. As a result, a given device may have three or four different codes that each link in the supply chain uses to refer to the same product. This lack of uniformity makes for flawed and/or delayed reporting and patient notification in the event of a recall.

As part of the FDA’s UDI mandate, all manufacturers of Class III medical devices must comply with the uniform coding of all products by September 24th, 2014. By starting to put a uniform coding system in place now, in the future, apps and push notifications can be configured to notify in a timely fashion all parties of a recall or problem before a tragedy occurs.

Eventually, UDI will be linked to Complaints and eMDR, which would help identify issues before adverse trends materialize. From a supplier management perspective, this could help alleviate serious issues before they become adverse events and recalls, in a proactive manner.

Although enforcement of the UDI mandate begins shortly there are still some parties within the medical device industry who may be resistant to adopting these new safety measures or an EQMS system.

Constant Communication: Supplier Relationship Management Challenges

If you don’t presently have an agreement in place with a supplier to offer real-time updates, they may not be willing to provide you with frequent updates. Existing agreements you have in place already may not be conducive to what you want to do. Additionally, a supplier may also not have access to something apart from a manual system. Because a QMS does not technically have a revenue stream, they may view it as a cost or overhead. However, to help sway their perception from a cost to a value generator, encourage suppliers to think about EQMS as

  • a pro-active solution from a compliance and risk standpoint
  • a tool for efficiency from a business standpoint
  • a solution that helps them identify, resolve and manage in near real-time for safer, reliable products with high quality from a customer and market standpoint

To learn more about how an EQMS offers additional benefits to manufacturers, listen to our webinar, EQMS for Manufacturing: Increasing Brand Reputation through High Quality Products.

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